Technical Transfer Specialist

The Tech Transfer Specialist is responsible for executing a formalized process for moving the manufacture of a drug from one facility, one scale or one drug life cycle phase to another. Tech transfer occurs multiple times during the life cycle of a drug as it progresses from lab to commercial production

Responsibilities

• Develop/edit a broad range of technical documents related to biopharmaceutical raw materials, including memos, assessments, specifications, and reports based upon compilation and analysis of supplier-provided and internal data.


• Draft, review, and approve Tech Transfer Plans and Assessments; Assemble raw materials for trial batch manufacture; Assure all raw materials are assembled and weighed for trial placebo batch for method comparison


• Translation of development formulations into manufacturing documentation to support process transfer activities with a thorough understanding of operational needs


• Compile raw material information from various sources (e.g. suppliers, CMOs, internal sites., regulatory/industry, compendia)


• Independently generate and executes plans to meet overall project schedule

• Bachelor’s in Chemistry, Biology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, or Pharmacy/Pharmaceutics required


• 2+ years of Technical Writing Experience in a Pharmaceutical environment; experience in a Tech Transfer, Operations or Product Development/Support preferred


• Superior written and verbal communications skills


• Excellent command of the English language and grammatical application thereof


• Keen attention to detail


• Highly organized


• Proficient with MS Word, including TOC, creating/using styles, footnotes, and cross references


• Competent with MS Excel, PowerPoint, and Outlook


• Familiar with SharePoint and electronic document management systems


• Able to multi-task and quickly adjust to changing priorities without sacrificing quality or timely completion of tasks